Nighttime Severe

Description

CVS Health® Nighttime Severe is a liquid formulation designed to relieve symptoms associated with cold and flu. This product contains the following active ingredients: Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; Diphenhydramine Succinate, an antihistamine; and Phenylephrine HCl, a nasal decongestant.

The formulation is intended to alleviate a range of symptoms, including fever, sore throat, minor aches and pains, nasal congestion, sinus pressure, sneezing, runny nose, and cough. It is presented in a honey flavor and is packaged in a 12 FL OZ (355 mL) bottle.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold and influenza. Specifically, it alleviates nasal congestion, sinus congestion and pressure, cough due to minor throat and bronchial irritation, and cough that may interfere with sleep. Additionally, it provides relief from minor aches and pains, headache, sore throat, fever, runny nose, and sneezing.

This medication also reduces swelling of the nasal passages, temporarily restores freer breathing through the nose, and promotes nasal and/or sinus drainage.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the prescribed dosage and administration guidelines. It is imperative to utilize only the dose cup provided with the medication to ensure accurate dosing. The maximum allowable dosage is four doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 30 mL every 4 hours. For children aged 6 to under 12 years, the dosage is 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a physician for appropriate dosing recommendations. The medication is not indicated for use in children under 4 years of age.

Healthcare professionals should monitor patients for adherence to these guidelines to prevent the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek guidance from a healthcare professional.

• History of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

• Use in children for the purpose of inducing sleep, as this is not an approved indication and may pose safety risks.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, under the following circumstances: if an adult consumes more than 4,000 mg of acetaminophen within a 24-hour period; if a child takes more than 5 doses in 24 hours; if it is taken concurrently with other medications containing acetaminophen; or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor if they experience a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting.

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, a cough that produces excessive phlegm, difficulty urinating due to an enlarged prostate gland, or a breathing problem such as emphysema or chronic bronchitis. Additionally, those with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should also consult a healthcare provider.

Patients should also be cautioned to consult a doctor or pharmacist before using this product if they are currently taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help right away, regardless of whether signs or symptoms are present.

Patients should discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 5 days in children or 7 days in adults; if fever worsens or lasts more than 3 days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts, as these may indicate a serious condition.

Side Effects

Severe adverse reactions associated with the use of acetaminophen include the potential for severe liver damage, particularly if an adult exceeds 4,000 mg in a 24-hour period, a child takes more than 5 doses in 24 hours, or if the product is used concurrently with other medications containing acetaminophen. Additionally, adults who consume three or more alcoholic drinks daily while using this product are at increased risk for liver damage.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants should also be advised to consult a healthcare provider if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should discontinue use and seek medical advice if pain, nasal congestion, or cough worsens or lasts longer than 5 days in children or 7 days in adults, if fever worsens or lasts more than 3 days, if redness or swelling occurs, or if new symptoms arise. A return of cough or the occurrence of cough with rash or headache that persists may indicate a serious condition requiring medical evaluation.

Patients with pre-existing conditions such as liver disease, heart disease, high blood pressure, glaucoma, thyroid disease, diabetes, or those experiencing cough with excessive phlegm, difficulty urinating due to an enlarged prostate, or chronic respiratory issues should consult a healthcare provider prior to use. Additionally, individuals taking blood thinners like warfarin or sedatives should seek advice from a doctor or pharmacist before using this product.

While using acetaminophen, patients may experience excitability, particularly in children, and marked drowsiness. It is recommended to avoid alcoholic beverages, and caution should be exercised when driving or operating machinery, as alcohol, sedatives, and tranquilizers may enhance drowsiness.

In the event of an overdose, immediate medical attention is crucial. Patients are advised to contact a Poison Control Center or seek medical help right away, even if no signs or symptoms are apparent, as prompt intervention is critical for both adults and children.

Drug Interactions

The concomitant use of certain medications may lead to significant interactions that require careful consideration.

Anticoagulants

• The use of warfarin, an anticoagulant, may elevate the risk of bleeding. Patients should be monitored closely for signs of hemorrhage, and dosage adjustments may be necessary based on coagulation parameters.

CNS Depressants

• Co-administration of sedatives or tranquilizers can enhance drowsiness. Caution is advised when engaging in activities that require mental alertness, and dosage adjustments may be warranted based on the patient's response.

Acetaminophen

• Concurrent use with any drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for hepatotoxicity. Patients should be advised to avoid such combinations.

Monoamine Oxidase Inhibitors (MAOIs)

• The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This is critical to prevent serious adverse effects associated with the interaction.

Laboratory Test Interactions

• Alcohol, sedatives, and tranquilizers may also increase drowsiness, which could affect the patient's ability to participate in laboratory tests or assessments. Monitoring and patient education regarding these effects are recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Nighttime Severe (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 15 mL every 4 hours. For children aged 4 to under 6 years, it is advised to consult a doctor before use. The product is not recommended for children under 4 years of age.

Healthcare professionals should be aware that excitability may occur, particularly in pediatric patients. Additionally, marked drowsiness is a potential side effect. If pain, nasal congestion, or cough worsens or persists beyond 5 days in children, or 7 days in adults, medical advice should be sought. Similarly, if fever worsens or lasts more than 3 days, further evaluation is necessary.

In the event of an overdose, immediate medical assistance should be obtained, or a Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the drug's metabolism and overall safety profile. Monitoring of liver function may be necessary to ensure the safe administration of the medication in this population.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management of an overdose may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use.

Excitability has been observed, particularly in children, and marked drowsiness may also occur.

No specific information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no specific information provided concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe skin reactions associated with acetaminophen use. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, excitability has been noted, particularly in pediatric populations. Marked drowsiness has also been reported among users.

Healthcare professionals are encouraged to advise patients to stop use and consult a doctor if any of the following occur: worsening pain, nasal congestion, or cough lasting more than 5 days in children or 7 days in adults; fever that worsens or persists beyond 3 days; presence of redness or swelling; emergence of new symptoms; or recurrence of cough accompanied by rash or headache lasting for an extended period. These symptoms may indicate a serious underlying condition.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Nighttime Severe, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)